PATIENTS DESERVE A BETTER IMPLANT SOLUTION

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1 PATIENTS DESERVE A BETTER IMPLANT SOLUTION

2 OSSDSIGN CRANIAL PSI BRINGING LIFE TO CRANIOPLASTY OssDsign is an innovator, designer and manufacturer of personalized bone replacement technology for cranial repair. We are surgeons, scientists and engineers committed to improving outcomes in cranioplasty. THE CHALLENGE: Eliminate lifelong risk There are two principal types of cranioplasty techniques the use of synthetic implants or the use of autologous bone flaps. Common complications following the use of conventional synthetic implants in large cranial defects includes infections and skin ruptures, which may lead to explantation. Furthermore, resorption of autologous bone is common among younger patients and frequently exceeds 20% of cases¹, sometimes reaching as high as 35%². For many patients the result is a lifetime of uncertainty and distress over infections, disfiguration and additional surgeries, as well as high healthcare costs all of which could be avoided. There is a need for a better performing technique in cranioplasty. References OUR SOLUTION: OSSDSIGN Cranial PSI Focused on the challenges in cranioplasty, surgeons at the Karolinska University Hospital in Stockholm, Sweden, in collaboration with biomaterials researchers at Uppsala University, developed a novel cranioplasty device based on an innovative design and a biocompa tible material composition OSSDSIGN Cranial PSI which have been in regular clinical use in Europe since By combining a stable and patientspecific titanium skeleton mesh and a biocompatible calcium phosphate material, OSSDSIGN Cranial provides a solution for a variety of cranioplasty needs. 1 Honeybul S, Morrison DA, Ho KM, et al. A randomized controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty. J Neurosurg Mar 18: Brommeland T, Rydning PN, Pripp AH, Helseth E. Cranioplasty complications and risk factors associated with bone flap resorption. Scand J Trauma Resusc Emerg Med Oct 6;23:75 We are surgeons, scientists and engineers committed to improving outcomes in cranioplasty

3 Perfect aesthetics regardless of complexity based on CAD design and 3D printing. Mosaic tile design with with inter-tile spacing that allows for fluid movement through the device. Stability and protection based on the 3D printed titanium skeleton. Easy handling and fixation with predesigned, customizable fixation arms. OSSDSIGN Cranial delivers a precise fit of patient-specific implants for a variety of cranioplasty needs INNOVATIVE MATERIAL MEETS FUNCTIONAL DESIGN OSSDSIGN Cranial is a biocompatible patient-specific implant, based on a mosaic-designed ceramic tile structure reinforced by a rigid, non-exposed titanium skeleton. Every implant is tailored to the individual patient s cranial defect based on CAD technology and 3D printing. The result is a precise fit of customdesigned implants for a variety of cranioplasty needs.

4 EASY AND RELIABLE ORDERING, HANDLING AND FIXATION For optimal results the scan thickness should be less than 1.0 mm. 1. CT-scan Prepare your CT data and upload it together with details about your case into our secure online system (HIPAA compliant). For the best possible results we recommend that you follow our CT scanning guidelines, available for download at OSSDSIGN Cranial represents an innovative and insightful approach to cranioplasty. Uniquely designed for every patient, OSSDSIGN Cranial reconstructs the skull defect, protects the brain and enhances the patient s cosmetic appearance. Delivered sterile and ready to use, in any shape or size (<200 cm²) desired, it provides a solution for a variety of cranioplasty needs. OSSDSIGN Cranial is easy to fixate to the skull with standard micro screws through the pre-desiged low-profile fixation arms. The titanium skeleton is embedded in the core of the implant s calcium phosphate tiles which are manufactured, cured and immobilized ready for surgery. The OssDsign CAD-design team have extensive experience in designing implants for cranial defects of various complexity. During the design process we work in close collaboration with you to ensure that we achieve an optimal solution for you and your patient. Our communication often includes the length, number and location of the fixation arms, as well as the aesthetic outcome, where we can provide you with recommendations based on our experience and knowledge. CAD design and 3D printing ensures a perfect fit with pre-designed and easy to use fixation arms. 2. Design and communication Withing 2 working days we will provide you with a digital design proposal. You will have complete insight and ability to influence the design in order to achieve the optimal solution for you and your patients. Once you have approved a final design, the manufacturing process will be initiated. 3. Delivery Your OSSDSIGN Cranial implant will be delivered 5 weeks after the final design have been approved. The implant is delivered sterile and ready for surgery. All implants are delivered sterile five weeks after design approval.

5 About OssDsign OssDsign is a Sweden-based medical technology company dedicated to creating regenerative implants for improved healing of bone defects. By combining the latest clinical insights and implant designs with a proprietary technology platform based on clinical development at Karolinska University Hospital in collaboration with material science experts at Ångström Laboratory at Uppsala University, OssDsign supplies an expanding range of tailored solutions for cranial repair. ossdsign.com REF Rev04 Always read Instructions for Use which accompany the product for indications, contraindications, warnings and precautions. +46(0) ossdsign.com info@ossdsign.com OssDsign AB, Virdings Allé 2, Uppsala, Sweden